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A Double-blind, Placebo-controlled Phase 2b Study to Evaluate the Efficacy and Safety of ARO-APOC3 in Adults with Severe Hypertriglyceridemia

Recruiting

The primary objective of the study is to evaluate the safety and efficacy of ARO-APOC3 in adults with SHTG and to select a dosing regimen for later stage clinical studies in this patient population.

I'm interested

All
18 Years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Based on medical history, evidence of TG ≥ 500 mg/dL and ≤ 4000 mg/dL at Screening
• Fasting TG ≥ 500 mg/dL at Screening
• Willing to follow diet counseling per Investigator judgment based on local standard of care
• Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception
• Willing to provide written informed consent and to comply with study requirements
Exclusion Criteria:

• Active pancreatitis within 12 weeks prior to first dose
• Any planned bariatric surgery or similar procedures to induce weight loss from consent to end of study
• Acute coronary syndrome event within 24 weeks of first dose
• Major surgery within 12 weeks of first dose
• Planned coronary intervention (e.g., stent placement or heart bypass) or any non-cardiac major surgical procedure throughout the study
• Uncontrolled hypertension
• Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B (HBV), seropositive for Hepatitis C (HCV)
• Uncontrolled hypothyroidism or hyperthyroidism
• Hemorrhagic stroke within 24 weeks of first dose
• Malignancy within the last 2 years prior to date of consent requiring systemic treatment (some exceptions apply) Note: additional inclusion/exclusion criteria may apply per protocol

Drug: ARO-APOC3, Drug: Placebo

Severe Hypertriglyceridemia

Clinics and Surgery Center (CSC)

Kathryn France - kafrance@umn.edu
Daniel Duprez
Phase 2
STUDY00013050
NCT04720534
See this study on ClinicalTrials.gov

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